• 1/26/2007
  • Gaithersberg, MD
  • press release
  • BusinessWire (home.businesswire.com)

GenVec, Inc. today announced that the first patient has been dosed in a Phase I/II trial with TNFerade™ for head and neck cancer at the University of Chicago Medical Center. GenVec is sponsoring two separate Phase I/II studies at the University of Chicago to explore the use of TNFerade as a second-line treatment for unresectable, recurrent tumors, and as a first-line treatment for elderly or frail patients. The trials are being funded by the National Cancer Institute.

The two separate trials, which will be led by principal investigators Everett Vokes, M.D., and Tanguy Seiwert, M.D., could enroll up to 70 patients with unresectable, recurrent tumors and up to 60 elderly or frail patients with new onset, locally advanced disease. The investigators will first determine best dose in each indication, and will assess safety and locoregional control of the cancer following TNFerade treatment as a component of standard of care.

“The start of these trials marks another milestone in our clinical progress with TNFerade,” stated Mark Thornton, M.D., M.P.H., Ph.D., GenVec’s senior vice-president of product development. “We know that local control is crucial for effective treatment of head and neck cancers, and is a respected regulatory endpoint. Since TNFerade is administered directly at the tumor site, it is ideally suited for these specific indications. TNFerade also has a well-established safety profile, so we believe it is a potentially appropriate treatment for elderly or frail cancer patients who cannot tolerate the cytotoxic effects of systemically administered cancer therapies. We look forward to continued progress in these clinical trials,” added Dr. Thornton.

About TNFerade™

TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFα), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFα in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.